Crohn Disease study: Risankizumab
Official title Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
ClinicalTrials.gov ID: NCT07872449
What this study is testing
What is Risankizumab?
This is an investigational medicine being studied as a potential treatment for Crohn's disease. It is designed to block a specific protein in the body called interleukin-23 to help reduce inflammation.
Also referred to as Skyrizi.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see how well risankizumab works for this type of Crohn's disease by looking at symptoms and MRI scans.
- Who it's for
- Adults who have Crohn's disease that has caused fistulas around the anus.
- What's involved
- Participants will receive the drug and have regular check‑ups and MRI scans to monitor their condition.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- 15 years of age or older
- Patients with an MRI-confirmed perianal fistula due to Crohn's disease
- Patients with a draining anal fistula (maximum of 2 internal openings and maximum of 3 external openings) persisting for at least 2 weeks
- Patients who have experienced inadequate response, diminished response, or intolerance to one or more of the following treatments in the past: ①...
- Patients who can agree to removal of the perianal seton by week 20 (week 20 ± 1 week) of administration, if patients already have setons inserted.
You likely can't join if
- Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fistulas)
- Patients with severe rectal and/or anal stricture and/or severe proctitis (defined as the presence of large ulcers exceeding 0.5 cm in the rectum)
- Patients with abscesses or fluid collections exceeding 2 cm
- Patients for whom MRI is contraindicated
- Patients with a history of risankizumab, mirikizumab, or guselkumab administration
- Patients who are refractory to three or more prior lines of advanced therapy
See the full eligibility criteria
- 15 years of age or older
- Patients with an MRI-confirmed perianal fistula due to Crohn's disease
- Patients with a draining anal fistula (maximum of 2 internal openings and maximum of 3 external openings) persisting for at least 2 weeks
- Patients who have experienced inadequate response, diminished response, or intolerance to one or more of the following treatments in the past: ① Antibiotics (ciprofloxacin or metronidazole): Treatment lasting one month...
- Patients who can agree to removal of the perianal seton by week 20 (week 20 ± 1 week) of administration, if patients already have setons inserted.
- Patients with draining fistulas that were drained at least 6 weeks prior to enrollment.
- Patients who have received a sufficient explanation regarding participation in this study, understood it fully, and provided their voluntary written consent, or patients whose legal representative received a sufficient...
- Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fistulas)
- Patients with severe rectal and/or anal stricture and/or severe proctitis (defined as the presence of large ulcers exceeding 0.5 cm in the rectum)
- Patients with abscesses or fluid collections exceeding 2 cm
- Patients for whom MRI is contraindicated
- Patients with a history of risankizumab, mirikizumab, or guselkumab administration
- Patients who are refractory to three or more prior lines of advanced therapy
- Patients who are intolerant to two or more prior lines of advanced therapy
- Patients previously treated with darvadstrocel
- Patients with a colostomy or ileostomy
- Patients with disease activity (CDAI) \> 400
- Patients receiving systemic steroids
- Patients requiring new treatment with immunomodulators or advanced therapies during the screening period
- Patients undergoing cytapheresis
- Patients with a history of malignancy (excluding carcinoma in situ)
- Patients with concomitant uncontrolled liver disease, hematologic disease, gastrointestinal disease (excluding Crohn's disease), endocrine disease, pulmonary disease, cardiac disease, neurological disease, psychiatric...
- Patients who underwent major surgery or suffered severe trauma within the past 6 months
- Patients who are breastfeeding, pregnant, or may be pregnant, or who plan to become pregnant during the study period
- Patients who showed persistent positivity for HBsAg and HBV-PCR, or seropositivity for HCV and quantitative HCV-PCR within 6 months prior to the start of the screening period
- Patients who received a live vaccine within 4 weeks prior to the start of risankizumab administration
- Patients with active tuberculosis
- Other patients deemed inappropriate for trial participation by the principal/ sub-investigator responsible
The study team makes the final eligibility decision.
Where it is enrolling
- Nishinomiya, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nishinomiya, Japan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.